The Effect of Adding Either Propofol or Ketamine to Magnesium and Lidocaine Infusions in Nasal Surgeries.

ConditionIntraoperative Bleeding

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18-60

SponsorAin Shams University

About this trial

Nasal surgeries are common day case procedures. Although surgical complications are rare, bleeding decreases surgical field visibility and may cause vascular, orbital or intracranial complications in addition to failure of procedure. So, it is crucial to maintain hypotensive anaesthesia to optimize the surgical field.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA I-II,

scheduled for elective nasal surgery

Disqualifiers

Patients with uncontrolled hypertension.

Patients with cardiac disease.

Patients with renal, hepatic or cerebral insufficiency.

Patients with coagulopathy or receiving drugs influencing blood coagulation.

Trial design

Design model

Parallel

Treatments tested in this trial

Intravenous Infusion of propofol, lidocaine, Magnesium sulfate
Drug
intravenous infusion of propofol 6-10 mg.kg-1.h-1, lidocaine (lidocaine 2% 400mg in 20 ml) bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1. the effect of either Propofol injection, or ketamine injection or dexmeditomidine injection on intraoperative bleeding
Intravenous infusion of ketamine, lidocaine, Magnesium sulfate
Drug
Patients will receive intravenous infusion of Ketamine 0.1-0.2 mg.kg-1.h-1 (intravenous infusion of propofol 6-10 mg.kg-1.h-1, lidocaine (lidocaine 2% 400mg in 20 ml) bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1. dose of 1 mg.kg-1), lidocaine bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1.
Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate
Drug
Dexmeditomidine (Precedex® 200 mcg.2ml-1) with a rate of 0.2-0.6 mcg.Kg-1.h-1. lidocaine bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Group PLM (propofol-lidocaine-magnesium)Active comparator 1 intervention

Group B: Group KLM (ketamine-lidocaine-magnesium)Active comparator 1 intervention

Group C: Group DLM (Dexmeditomidine-lidocaine-magnesium)Active comparator 1 intervention

Trial outcomes

Primary outcomes

surgical field using the average category scale (ACS).

Degree of surgical field bleeding

Time frame

During the operation

Secondary outcomes

sedation using Ramsy sedation score

Degree of sedation using Ramsy sedation score

Time frame

First hour postoperative

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov

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